Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery

Not Applicable

Completed

• Conditions: Skin Cancer
• Interventions: Other: Wuennenberg Modified Curved Iris Scissors; Other: Traditional Curved Iris Scissors; Other: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors

• Registration Number: NCT04413383
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

Every year thousands of dermatologic surgery procedures are performed at the University of Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and biopsies. Surgery is known to cause anxiety for patients and with these procedures performed under local anesthetic on awake patients', the sights, sounds, and smells experienced during the procedure can lead to an increase in their anxiety or affect their overall perception of the experience. From performing and assisting with dermatologic surgery the noise associated with the use of the traditional curved Iris scissors provokes an increase in patient awareness to the procedure resulting in increased anxiety, triggering of the vasovagal response, and expressions of annoyance by the patient. However, the modified curved Iris scissors make almost no noise. The Investigators hypothesize that if patients were given the comparative experience of both types of curved Iris scissors during dermatologic surgery, then they will choose the modified curved Iris scissors because the lack of noise will be perceived as more pleasant experience. Our objective is to perform a prospective, single blinded, randomized controlled trial to determine how the noise of traditional curved Iris scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during dermatologic surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Study Start: 2020-12-21
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Adult (18 years or older)
• non-pregnant
• patients being treated with Mohs micrographic surgery or excision on the head and neck

Exclusion Criteria

• Patients not meeting above inclusion criteria will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Curved Iris Scissors	Wuennenberg Modified Curved Iris Scissors	The Wuennenberg modified curved Iris scissors are used during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.
Traditional Curved Iris Scissors	Traditional Curved Iris Scissors	The traditional curved Iris scissors are used to during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.
Comparative Experience	Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors	Both the traditional and modified curved Iris scissors are used and patients are asked which they prefer. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.

Primary Outcome Measures

Name	Time	Method
Extent that patient notices curved Iris scissors	3 to 8 hours (length of the patients Mohs Surgery)	Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.
Extent that patient is bothered by the curved Iris scissors	3 to 8 hours (length of the patients Mohs Surgery)	Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.
Patients Preference of curved Iris scissor	3 to 8 hours (length of the patients Mohs Surgery)	Patient is asked during the procedure if they prefer "1," surgeon uses the traditional curved Iris scissors, or "2" and the surgeon uses the Wuennenberg modified curved Iris scissors. The patient indicates their preference by responding "1 or 2." After the procedure the patient completes a questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices and is bothered by the curved iris scissors.

Trial Locations

Locations (1)

UPMB; 🇺🇸 Columbia, Missouri, United States